Brief: Abeona Therapeutics Provides Regulatory Update On Pz-cel

Abeona Therapeutics

22/04/2024 21:11

April 22 (Reuters) - Abeona Therapeutics Inc  ABEO.O :
    * ABEONA THERAPEUTICS PROVIDES REGULATORY UPDATE ON PZ-CEL
    * ABEONA THERAPEUTICS INC - ANTICIPATES COMPLETING AND
SUBMITTING
REQUESTED CMC INFORMATION IN 3Q 2024
    * ABEONA THERAPEUTICS INC - ANTICIPATES COMPLETING AND
SUBMITTING
REQUESTED CMC INFORMATION IN 3Q 2024
    * ABEONA THERAPEUTICS INC - ANTICIPATES COMPLETING AND
SUBMITTING
REQUESTED CMC INFORMATION IN 3Q 2024
    * ABEONA THERAPEUTICS INC: RECEIVES FDA COMPLETE RESPONSE
LETTER
(CRL) BASED ON NEED FOR ADDITIONAL CMC INFORMATION
    * ABEONA THERAPEUTICS INC - CRL DID NOT IDENTIFY
DEFICIENCIES
RELATED TO CLINICAL EFFICACY OR CLINICAL SAFETY DATA IN BLA
    * ABEONA THERAPEUTICS INC: RECEIVES FDA COMPLETE RESPONSE
LETTER
(CRL) BASED ON NEED FOR ADDITIONAL CMC INFORMATION
    * ABEONA THERAPEUTICS INC - CRL DID NOT IDENTIFY
DEFICIENCIES
RELATED TO CLINICAL EFFICACY OR CLINICAL SAFETY DATA IN BLA
    * ABEONA THERAPEUTICS INC - NO NEW CLINICAL STUDIES
REQUESTED BY
FDA TO SUPPORT APPROVAL
    * ABEONA THERAPEUTICS INC - NO NEW CLINICAL STUDIES
REQUESTED BY
FDA TO SUPPORT APPROVAL
    * ABEONA THERAPEUTICS INC - RECEIVES FDA COMPLETE RESPONSE
LETTER
(CRL) BASED ON NEED FOR ADDITIONAL CMC INFORMATION
    * ABEONA THERAPEUTICS INC - RECEIVES FDA COMPLETE RESPONSE
LETTER
(CRL) BASED ON NEED FOR ADDITIONAL CMC INFORMATION
    * ABEONA THERAPEUTICS INC - RECEIVES FDA COMPLETE RESPONSE
LETTER
(CRL) BASED ON NEED FOR ADDITIONAL CMC INFORMATION

Source text for Eikon:  ID:nGNX8dr2RG 
Further company coverage:  ABEO.O 

 ((Reuters.Briefs@thomsonreuters.com;))